Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients (BRIDION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01911520
First received: July 23, 2013
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function.

Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.

Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.

Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.

At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.

We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.


Condition Intervention Phase
Morbidly Obese Patients.
Drug: Sugammadex 2 mg/kg
Drug: Sugammadex. 4 mg/kg
Procedure: Neuromuscular monitoring.
Procedure: Clinical evaluation of residual curarization .
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Time to complete recovery of muscle relaxation, 30 minutes after end of surgery. [ Time Frame: 30 minutes after end of surgery. ] [ Designated as safety issue: Yes ]
    Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.

  • Time to complete recovery of muscle relaxation, 1 hour after the end of surgery. [ Time Frame: 1hour after end of surgery. ] [ Designated as safety issue: Yes ]
    Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.

  • Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery. [ Time Frame: 1hour 30 minutes after end of surgery. ] [ Designated as safety issue: Yes ]
    Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.

  • Time to complete recovery of muscle relaxation, 2 hours after the end of surgery. [ Time Frame: 2 hours after end of surgery. ] [ Designated as safety issue: Yes ]
    Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.


Secondary Outcome Measures:
  • Need/use of rescue medication at the end of surgery [ Time Frame: The hours following the end of surgery. ] [ Designated as safety issue: Yes ]
    Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMI < 50, Total Body Weight (TBW), 2mg/kg
Patients with a BMI < 50, who will be dosed according to total body weight.
Drug: Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI < 50, TBW, 4 mg/kg
Patients with a BMI < 50, who will be dosed according to total body weight.
Drug: Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI < 50, Ideal Body Weight (IBW), 2 mg/kg
Patients with a BMI < 50, who will be dosed according to ideal body weight.
Drug: Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI < 50, IBW, 4 mg/kg
Patients with a BMI < 50, who will be dosed according to ideal body weight.
Drug: Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI > 50, TBW, 2mg/kg
Patients with a BMI > 50, who will be dosed according to total body weight.
Drug: Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI > 50, TBW, 4mg/kg
Patients with a BMI > 50, who will be dosed according to total body weight.
Drug: Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI >50, IBW, 2 mg/kg
Patients with a BMI > 50, who will be dosed according to ideal body weight.
Drug: Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI >50, IBW, 4 mg/kg
Patients with a BMI > 50, who will be dosed according to ideal body weight.
Drug: Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Procedure: Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Procedure: Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.

Detailed Description:

Flowchart :

72 participants

Stratification

BMI<50 BMI >50

Randomization Randomization

TBW IBW TBW IBW

2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9

TBW : Total Body Weight IBW : Ideal Body Weight

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • ASA I-II-III
  • Age 18 - 65 year
  • Male or female
  • BMI > 30

Exclusion criteria :

  • Renal failure
  • Liver dysfunction
  • Breastfeeding female patients, or female patients without reliable contraception
  • Neuromuscular disease
  • Malignant hyperthermia or a family history of malignant hyperthermia
  • Allergy for neuromuscular blocking agents or other medications used during general anesthesia
  • Infectious disease or patients with fever
  • Patients who already received rocuronium or sugammadex on the day of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911520

Locations
Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Jurgen Van Limmen, MD Ghent University Hospital
Principal Investigator: Luc De Baerdemaeker, MD, PhD Ghent University Hospital
Principal Investigator: Koen Reyntjens, MD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01911520     History of Changes
Other Study ID Numbers: 2010/207, 2009-016857-16
Study First Received: July 23, 2013
Last Updated: July 26, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on October 23, 2014